Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis

Phase 2

Completed

• Conditions: Eosinophilic Bronchitis; Steroid and/or Prednisone Dependent Asthma
• Interventions: Drug: Placebo; Biological: Omalizumab (Xolair)

• Registration Number: NCT02049294
• Lead Sponsor: McMaster University

Brief Summary

The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.

This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.

Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils \<3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).

Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Study Start: 2014-03
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omalizumab (Xolair)	Placebo	Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Placebo (Normal Saline)	Omalizumab (Xolair)	0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab

Primary Outcome Measures

Name	Time	Method
Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.	From Week 12 to Week 32
Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32	From Week 0 to Week 12 and Week 12 to week 32

Secondary Outcome Measures

Name	Time	Method
Blood eosinophils	From Week 0 to week 32
Forced Expired Volume in 1 second (FEV1)	From Week 0 to Week 32
Fraction of exhaled nitric oxide (FeNO)	From Week 0 to Week 32
Asthma Control Questionnaire	From Week 0 to Week 32
Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)	From Week 0 to Week 32
Provocative concentration causing a 20% drop in FEV1 (PC20)	From Week 0 to Week 32
change in % sputum eosinophil	From Week 0 to Week 32

Trial Locations

Locations (5)

Richard Leigh; 🇨🇦 Calgary, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Montreal; 🇨🇦 Montreal, Quebec, Canada

University of Laval; 🇨🇦 Laval, Quebec, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada